The results of the cooperation show that the five varieties of the Andrographis paniculata and the United States Pharmacopoeia

Business News Agency October 29th The Fourth China-US Pharmacopoeia International Forum was held in Hangzhou on the theme of “Drug Standards and Drug Manufacturing Quality Control”. The Deputy Director of the State Food and Drug Administration (SFDA) and Secretary General of the State Pharmacopoeia Commission Wu Hao and Roger L. Williams, CEO of the US Pharmacopoeia Commission, attended the meeting and delivered speeches. Experts from 11 countries conducted in-depth discussions.

Cooperation has begun to show results

In 2008, China and the United States formally signed the "Memorandum of Understanding on Cooperation" for pharmacopoeia work and established the common goal of cooperation between the two parties - ensuring the quality and safety of public drug use and promoting the healthy development of the pharmaceutical industry. The two sides jointly established a joint working group and carried out a series of work, the most important of which is the development of quality standards and physical standards applicable to one or both of the pharmacopoeias.

“The results of the current standard cooperation have initially appeared. In terms of standard work, the Chinese Pharmacopoeia Commission has provided 99 varieties of Chinese medicine to the United States, and the US Pharmacopoeia Commission is reviewing and reviewing it. It has been determined that Andrographis, Centella asiatica, Cinnamon, Artemisia annua, Ganoderma lucidum In the US Code of Dietary Supplements; in terms of working relationships, a meeting mechanism for high-level mutual visits was established; in addition, the Chinese Pharmacopoeia Commission also assisted the United States Pharmacopoeia in the translation of the Chinese version of the United States Pharmacopoeia, Wu said.

Dennis KJ Gorecki, chairman of the US Pharmacopoeia Dietary Supplements Expert Committee, reviewed the results of the signing of the Memorandum of Understanding on Cooperation and the work of the China-US Pharmacopoeia Commission Advisory Committee on Standards for Components and Preparations of Traditional Chinese Medicine established in August 2009. Dennis KJ Gorecki also revealed that, in addition to the standards that have been confirmed through public review and will soon be accepted for adoption, the United States Pharmacopoeia has also developed the standards for Chinese Salvia and Chinese Salviae Militaris.

"Once the United States Pharmacopoeia obtains the required reference materials, public review and commentary will soon appear on the United States Pharmacopoeia's Internet Pharmacopeial Forum," said Dennis KJ Gorecki.

Internationalization gradually deepens

With the further increase in the degree of concentration of China's pharmaceutical industry, the desire of China's pharmaceutical manufacturers to go international is also growing. In this process, the voice of applying new technologies and new products to drug standards and adopting advanced methods of international drug standards is also increasing.

In fact, the Chinese Pharmacopoeia has been seeking and conducting extensive international cooperation. According to reports, the SFDA and the EDQM (European Agency for the Quality of Medicines) conducted in-depth talks on the pharmacopoeial standards and the European Pharmacopoeia Adaptability Certificate (COS) in July this year; currently there are 37, Quanzhou, Honghua, and the mantle. The standards for the four varieties have been recommended by the French Pharmacopoeia Commission and have been included in the European Pharmacopoeia; both China and EU have agreed to discuss further the development of standards together; recently, the China Pharmacopoeia Commission and the British Pharmacopoeia Commission have also signed cooperation agreements. Pharmacopoeia standards for Chinese herbal medicines were developed and the scope of cooperation was extended to areas such as pharmaceutical preparations. The first phase of the cooperation will study the formulation of quality standards for 35 Chinese herbal medicine varieties.

Roger L. Williams pointed out that the pharmacopoeias of all countries in the world are facing some problems. Therefore, it is necessary to strengthen cooperation and share information so as to promote the integration of pharmacopoeias among countries and achieve international integration. In this regard, Wu Hao proposed suggestions for cooperation: “One is to establish a coordination mechanism for international Pharmacopoeia cooperation, strengthen exchanges between various Pharmacopoeia institutions, and enhance mutual understanding through mutual visits, and jointly explore ways for the international Pharmacopoeia cooperation mechanism; Strengthen basic cooperation and jointly develop drug standards drafting, research methods, and coordination of technical specifications. Third, regular international forums are held. The successful holding of the China-US Pharmacopoeia Forum fully demonstrates that international forums are not only technical exchange platforms, but also A platform for mutual coordination and cooperation among countries."